Navigation Links
FDA Approves New Drug to Fight Advanced Prostate Cancer
Date:5/15/2013

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo, marketed by Wayne, N.J.-based Bayer Pharmaceuticals, was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

More information

Find out more about prostate cancer at the U.S. National Cancer Institute.

-- E.J. Mundell

SOURCES: May 15, 2013, news release, U.S. Food and Drug Administration; American Cancer Society


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves Morning-After Pill Without a Prescription
2. FDA Approves New “Gummy Bear” Breast Implants, But Albany Plastic Surgeon Urges Caution
3. FDA Approves 1st in New Class of Type 2 Diabetes Drugs
4. FDA Approves New Multiple Sclerosis Drug
5. FDA Approves Drug for Older Women Experiencing Painful Sex
6. FDA Approves Bionic Eye to Help Against Rare Vision Disorder
7. MSSD Approves of the Encinitas School District’s Holistic Education
8. FDA Approves 3 New Drugs for Type 2 Diabetes
9. FDA Approves 1st Skin Patch to Combat Migraines
10. Environmental Protection Agency Approves MOMS by OdorXit as a Disinfectant
11. FDA Approves New Type of Flu Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves New Drug to Fight Advanced Prostate Cancer
(Date:1/22/2017)... Aliso Viejo, California (PRWEB) , ... January 22, 2017 , ... ... in Photo Cloud to create a beautiful 3D slideshow with complete ease," said Christina ... from the Generators browser to place in the FCPX timeline. Presets include ...
(Date:1/21/2017)... Raton, FL (PRWEB) , ... January 21, 2017 , ... ... Germany, announced it is bringing its product to the United States as part of ... over the last 25 years, Alcovit aims to reduce the productions of nasty toxins ...
(Date:1/21/2017)... ... January 21, 2017 , ... Phytocéane invites you to ... the rest of the world with ZANZIBAR SHOWER GEL. Inspired by the beauty of ... Virgin Coconut Oil and moisturizing vegetal coral to create this gentle, crystal-clear shower gel ...
(Date:1/21/2017)... CA (PRWEB) , ... January 21, 2017 , ... ... opening of its new medical office in Petaluma, located at 167 Lynch Creek ... room, access to SRO sports medicine and rehabilitation services and on-site ...
(Date:1/20/2017)... ... ... Spectrum Aquatics Launches New ADA Portable Motion Trek BP 300 Lift. Built for durability, this ... wheels, it can be wheeled out of the way and stored when not in use. ... have transformed the feedback from customers into specific enhancements and created a new product that ...
Breaking Medicine News(10 mins):
(Date:1/20/2017)... Jan. 20, 2017  Palladian Health, a leading ... the launch of an opioid management program which ... opioids and helps stem the growing tide of ... to treat chronic non-cancer pain (back pain, neck ... and lack of evidence regarding long-term effectiveness. ...
(Date:1/20/2017)... VAE, January 20, 2017 ... Bedarf an Nothilfe   Die internationale humanitäre Stadt ... Hilfsgüter zu schaffen   Seine Hoheit ... der VAE sowie Herrscher von Dubai ... Stadt der Hilfe (International Humanitarian City IHC) zu verdreifachen, ...
(Date:1/19/2017)... LONDON , Jan. 19, 2017 ... 2022 Summary GlobalData,s new report, "Germany Cataract ... data on the Germany Cataract Surgery Devices market. The ... (in units) and average prices (USD) within market segements ... The report also provides company shares and distribution shares ...
Breaking Medicine Technology: